GlobeNewswire·Aug 31, 2026, 4:01 PM ET

PMV Pharmaceuticals Announces Updated Promising Rezatapopt Monotherapy Interim Ovarian Cancer Data From PYNNACLE Phase 2 Pivotal Trial

Overall response rate of 46% observed among 76 evaluable patients in the ovarian cancer cohort with a median duration of response of 10.0 months
Recent FDA interaction supports NDA submission strategy for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer with submission planned in first quarter of 2027
PMV plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts at a medical conference in fourth quarter of 2026
Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE trial has been completed
The efficacy population included 76 patients with 35 responses consisting of four confirmed complete responses, 29 confirmed partial responses, & two unconfirmed partial responses
Median time to response was 1.3 months based on confirmed responses
Safety profile remains favorable with mostly Grade 1 & 2 treatment-related adverse events & a low 5% discontinuation rate due to treatment-related adverse events
Rezatapopt is a first-in-class small molecule p53 reactivator with Fast Track & Orphan Drug Designation for specific indications
The ongoing Phase 1/2 PYNNACLE trial is evaluating rezatapopt across approximately 70 sites in five cohorts including ovarian, lung, breast, endometrial cancers, & other solid tumors